Presentation before the FDA - Combination Tresiba/Victoza

I’ve been fortunate to have the opportunity to speak before the FDA on the hearing tomorrow (Tuesday, May 24) considering the approval of a combination of insulin degludec (Tresiba) and liraglutide (Victoza). I had to apply for a slot of about 2-3 minutes. I’ve shown below my written statement and my oral statement will be some variant. The public time slot is 1-2pm (EST) and it will be webcast. If you are interested you can listen in. If you have any thoughts on what else I should say in representing the patient community I’d like to hear it.

The meeting webcast can be accessed at the following web address:
https://collaboration.fda.gov/emdac0516/
Note: At the access page, please sign in as a guest. No password is required.

My name is Brian, I have had type 2 diabetes for 11 years. I wish to speak to you today about my experiences as a patient with the effectiveness and quality of life issues associated with GLP-1 drugs and insulin use. I believe that my experiences mirror what many other type 2 patients encounter. I cycled through essentially all the type 2 medications, including Byetta and Victoza. The GLP-1 drugs really helped my blood glucose responses to meals, but I still suffered from constantly high fasting blood sugars. And at the time, there were literally no type 2 medications that would help my fasting blood sugars. I ended up having to start insulin to deal with my fasting blood sugars. And at the time (six years ago) I had no option to combine a GLP-1 with a basal insulin (Byetta was approved as a separate add on to Lantus only in 2011). Instead, I had to move to a full insulin regime taking 4-5 injections a day, counting my carbs and moving instantly to being fully insulin dependent meaning basal insulin and mealtime insulin. I would dearly have liked to have had the option combining Liraglutide and insulin degludec and have one injection and one co-pay. Liraglutide would have controlled my blood sugars from meals without having to closely count and dose a bolus insulin (that is very easy to get right or wrong) and degludec would have finally controlled my fasting blood sugars. I would point out to the committee that switching to a full insulin regime is a significant hurdle for patients as well as doctors, who don’t always have time to train them properly. And it’s hard to take insulin for each meal and do it right and avoid hypoglcyemia and hyperglycemia! The ability of patients to properly implement an insulin regime is nowhere near 100%. A combination of liraglutide and insulin degludec represents a much more implementable regime for patients – liraglutide doesn’t cause hypoglcyemia like insulin does, it doesn’t cause weight gain, it makes people less hungry, and this means it can be more effective. And because this combination is a lot easier to implement and less of a burden on patients it really improves quality of life. And when you improve my quality of life, you probably make it more likely that I’ll take my medicine more.

In summary, as a type 2 patient, I encourage you to consider how the simplified treatment regime of using a combination of liraglutide and insulin degludec may improve effectiveness through better adherence to treatment as well as improve the overall quality of life by reducing patient burden.

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@Brian_BSC Thanks Brian for sharing this. I am a Tresiba user and have been very interested in many of the success stories with Victoza. I know several people with Type 1 who see incredible benefits with the drug. I hope to tune in!

Thank you very much for posting this, Brian!

And thank you for taking the time to apply and making the effort to go and speak to the FDA! Thank you on behalf of so many!

I won’t be able to listen in at the right time tomorrow. do you know whether it will be accessible after the meeting?

Best wishes!

marty1492

@Brian_BSC I listened to the entire hour for the public time slot. I may be prejudiced, but I thought you hit it out of the park!! several of us were in the chat room while it was on. (could you hear me cheering?) I liked your very personal story and bringing in the common misconception by T2s that insulin = failure, and your own doctor’s reluctance to prescribe.

did you stay for the discussion afterwards? once I heard the word “titration” I was lost. any insights you gained from the experience?

Thank you for taking the time to go to this!

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I enjoyed listening as well, Brian!

Your willingness to take charge of your own insulin needs was such a counterpoint to the other speaker who mentioned only 12% of patients wanting to discuss bolus insulin with their doctors.

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Thanks @MarieB and @BeastOfGevaudan. I was really pleased to be able to do this. I’m glad you thought my presentation went well. Obviously I ended up revising my statement above based on feedback I got. And then before I was to go on I was talking with Dr. Steven Edelman and added some further extemporaneous comments about patients making their own decisions about risk.

I had a great time. I had the opportunity to talk with Dr. Edelman as well as former Miss America Nicole Johnson as well as the other speakers and very prominent people in the diabetes field. I’ll be writing more about this in coming days and posting pictures as well.

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so I saw this morning the panel voted 16-0 to approve this new combo drug, iDegLira

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Thanks @MarieB. When I get a chance I’ll be writing about this. I would note that this hearing was an advisory panel and the recommendation to the FDA is for approval, but this doesn’t mean it is approved. As an observer the evidence presented to the panel was compelling that this combination drug is both quite effective and is safe.

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Hi Brian, Read this thread today on a search of Tresiba and Victoza. Was a drug yet released? A combo? I am starting Victoza tomorrow as Trulicity is no longer working as well. I lowered my A1C to 8 from 9.1 in 3 months, so an improvement. I initially lost 5 pounds on Trulicity, but at doctor today I had not lost any weight on their scale.

I am wondering thoughts on Tresiba with Victoza and hoping for some weight loss and lower blood sugars too. Thanks!

Yes, the combo is called Xultophy and is released. You may find it is totally affordable because it is a new drug.

Thanks! Maybe I will try the separate dose first to see how it works before trying the combo…good to know!